A randomized study of ganetespib, a heat shock protein 90 inhibitor, in combination with docetaxel versus docetaxel alone for second-line therapy of lung adenocarcinoma (GALAXY-1).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. CRA8007-CRA8007 ◽  
Author(s):  
Suresh S. Ramalingam ◽  
Glenwood D. Goss ◽  
Zoran Gojko Andric ◽  
Igor Bondarenko ◽  
Bojan Zaric ◽  
...  
Keyword(s):  
Heat Shock ◽  
Heat Shock Protein ◽  
Randomized Study ◽  
Heat Shock Protein 90 ◽  
Second Line ◽  
Second Line Therapy ◽  
Daily News ◽  
Online Supplement ◽  
Line Therapy ◽  
Final Text

CRA8007 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Monday, June, 3, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News.

A randomized study of ganetespib, a heat shock protein 90 inhibitor, in combination with docetaxel versus docetaxel alone for second-line therapy of lung adenocarcinoma (GALAXY-1).

2013 ◽  
Vol 31 (18_suppl) ◽  
pp. CRA8007-CRA8007 ◽  
Author(s):  
Suresh S. Ramalingam ◽  
Glenwood D. Goss ◽  
Zoran Gojko Andric ◽  
Igor Bondarenko ◽  
Bojan Zaric ◽  
...  
Keyword(s):  
Heat Shock ◽  
Heat Shock Protein ◽  
Lung Adenocarcinoma ◽  
Biological Effects ◽  
Single Agent ◽  
Heat Shock Protein 90 ◽  
Phase Iii ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

CRA8007 Background: Heat shock protein 90 chaperone function is critical for the biological effects of several oncoproteins. Ganetespib (G) is a highly potent 2nd-generation Hsp90 inhibitor with a favorable safety profile and single-agent clinical activity. Methods: Based on synergistic preclinical interactions between docetaxel (D) and G, we conducted a randomized (1:1), international open-label study of D with or without G. Patients with advanced lung adenocarcinoma, one prior systemic therapy, and ECOG PS 0/1 were included. D was given at 75 mg/m2 on day 1 of a three-week cycle. In the experimental arm, D was given on day 1 and G at 150 mg/m2 on days 1 and 15. The co-primary endpoints were PFS in patients with elevated LDH (eLDH) levels, or tumors harboring KRAS mutations. Key secondary endpoints were OS and PFS in all adenocarcinoma patients. Target enrollment was 240 adenocarcinoma, 120 eLDH, and 80 mKRAS patients. Statistical tests are 1-sided. Results: Enrollment of 255 adenocarcinoma patients completed in November 2012; results are reported for this population. Patient characteristics were balanced (median age 60 years, males ~60%, PS 0 ~40% and never-smoker ~25%). For D+G vs. D the median number of cycles delivered was 5 vs. 4; the grade 3/4 adverse events were neutropenia 38% vs. 37%; fatigue 4% vs. 3%; anemia 7% vs. 6%; diarrhea 3% vs. 0; fever with neutropenia 8% vs. 2%. At the time of abstract submission OS HR was 0.69 (90% CI 0.48 to 0.99, p=0.093), the PFS HR was 0.70 (90% CI 0.53 to 0.94, p=0.012), and the ORR was 15% vs 11%, favoring D+G. For patients that were enrolled >6 months after diagnosis of advanced NSCLC (N=175; 69%), a prespecified stratification factor, the OS HR was 0.41 (90% CI 0.25 to 0.67, p=0.0009), the PFS HR was 0.47 (90% CI 0.32 to 0.69, p=0.0005), and the ORR was 16% vs 12%. Updated results for both populations above, as well as for the eLDH and mKRAS subsets, will be presented. Conclusions: D+G demonstrated improvement in OS, PFS, and ORR over D alone for second-line therapy of lung adenocarcinoma. A phase III study in second-line advanced adenocarcinoma patients (> 6 months from diagnosis) is ongoing (GALAXY-2). Clinical trial information: NCT01348126.

Axitinib versus sorafenib as second‑line therapy in Asian patients with metastatic renal cell carcinoma (mRCC): Results from a registrational study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. LBA4537-LBA4537
Author(s):  
Shukui Qin ◽  
Feng Bi ◽  
Ying Cheng ◽  
Jun Guo ◽  
Xiu Bao Ren ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Second Line ◽  
Second Line Therapy ◽  
Daily News ◽  
Online Supplement ◽  
Asian Patients ◽  
Line Therapy ◽  
Final Text

LBA4537 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.

CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. CRA1002-CRA1002 ◽  
Author(s):  
Hope S. Rugo ◽  
William Thomas Barry ◽  
Alvaro Moreno-Aspitia ◽  
Alan P. Lyss ◽  
Constance Cirrincione ◽  
...  
Keyword(s):  
Metastatic Breast ◽  
Phase Iii ◽  
First Line ◽  
Daily News ◽  
Phase Iii Trial ◽  
Online Supplement ◽  
First Line Therapy ◽  
Line Therapy ◽  
Locally Recurrent ◽  
Final Text

CRA1002 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Monday, June 4, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News.

Randomized proteomic stratified phase III study of second-line erlotinib (E) versus chemotherapy (CT) in patients with inoperable non-small cell lung cancer (PROSE).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. LBA8005-LBA8005
Author(s):  
Chiara Lazzari ◽  
Silvia Novello ◽  
Sandro Barni ◽  
Michele Aieta ◽  
Filippo De Marinis ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
Second Line ◽  
Small Cell Lung ◽  
Daily News ◽  
Online Supplement ◽  
Phase Iii Study ◽  
Final Text

LBA8005 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Monday, June 3, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News.

scholarly journals The role of rituximab in adults with warm antibody autoimmune hemolytic anemia

Blood ◽  
2015 ◽  
Vol 125 (21) ◽  
pp. 3223-3229 ◽  
Author(s):  
Daan Dierickx ◽  
Alain Kentos ◽  
André Delannoy
Keyword(s):  
Hemolytic Anemia ◽  
Autoimmune Hemolytic Anemia ◽  
Randomized Study ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
First Line Therapy ◽  
Line Therapy

Abstract Warm antibody hemolytic anemia is the most common form of autoimmune hemolytic anemia. When therapy is needed, corticosteroids remain the cornerstone of initial treatment but are able to cure only a minority of patients (<20%). Splenectomy is usually proposed when a second-line therapy is needed. This classical approach is now challenged by the use of rituximab both as second-line and as first-line therapy. Second-line treatment with rituximab leads to response rates similar to splenectomy (∼70%), but rituximab-induced responses seem less sustained. However, additional courses of rituximab are most often followed by responses, at the price of reasonable toxicity. In some major European centers, rituximab is now the preferred second-line therapy of warm antibody hemolytic anemia in adults, although no prospective study convincingly supports this attitude. A recent randomized study strongly suggests that in first-line treatment, rituximab combined with steroids is superior to monotherapy with steroids. If this finding is confirmed, rituximab will emerge as a major component of the management of warm antibody hemolytic anemia not only after relapse but as soon as treatment is needed.

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